"The technical rectification plan has been completed. Once approved by the AQSIQ, it will immediately start rectifying the assembled machines at all relevant hospitals." On March 1st, GE Healthcare officials said that the company has decided to conduct self-examination. To ensure full compliance with national standards.

Prior to this, the AQSIQ issued a “warning notice”, saying that the Aestiva/57100 and Aespire type anesthesia systems produced by the American company Datex-Ohmeda (Inc) found serious safety hazards during inspection and supervision. . Dern Europe and the United States announced in 2003 by GE acquisitions, and finally merged into a GE medical business in 2005.

The above "warning notice" revealed that in recent years, the country has imported 987 anesthesia systems, which are distributed in clinical hospitals throughout the country. It is pre-judgment that more than 700 of these devices have the above-mentioned unqualified conditions.

Different standards understand

The registered agency and after-sales service organization for the Aespire and Aestiva/57100 anesthesia systems produced by Dehn Europe and the United States is GE Healthcare Trade Development (Shanghai) Co., Ltd. The two models produced by Europe and the United States do not provide a method for connecting backup oxygen. Oxygen and nitrous oxide are confused with each other, and do not meet the requirements of the related clauses of GB9706.29-2006 and GB7144-1999.

In response, the above-mentioned GE Healthcare official stated that the reason for the problem lies in the fact that domestic and foreign countries have different understandings of the method of connecting backup oxygen supply and the color standard used. China uses GB7144-1999 gas cylinder color and marking, and internationally Uses ISO 32 medical cylinder colors and markings.

"Popularly speaking, for the access of spare oxygen, in the above-mentioned models of Europe and the United States, through the central air supply transfer entrance, it is also possible to supply spare oxygen, but the General Administration of Quality Supervision, Inspection and Quarantine requires that there must be a separate outlet." Explaining that, in fact, the international practice is actually the former's mode of operation. As for the confusion between oxygen and laughter, in fact there is a clear text on the interface. “Doctors will never be mistaken.”

The person stressed that this different application will not cause the patient's safety.

An anesthesiologist from a tertiary hospital told the reporter that Occidental is the mainstream brand in imported anesthesia machines. Among the anesthetic equipment used in Europe and the United States, the highest end is the anesthesia workstation ADU, and the Aespire type is based on the configuration price of about 170,000 to 300,000. The price of Aestiva/57100 is about 250,000. Talking about the confusion between oxygen and laughter, he also said, "Laughing is spare, and it is used only rarely."

GE medical personnel stressed that "after the rectification, the company's new production and import of anesthesia system will surely fully comply with national standards."

On the official website of the FDA (United States Food and Drug Administration), the specification Aestiva 3000 produced by Dehn Europe and the United States in 2002 was also accused of having a major security risk. According to the FDA document, the Dehn-European anesthesia system will use the oxygen in the reserve oxygen tank first. However, this model is not the model that was named by AQSIQ.

Anesthesia market competition

GE Medical Group is a subsidiary of GE and has annual sales of US$14 billion.

The annual demand for domestic anesthesia machines is about 5,000 units, including 3,000 low-grade anesthesia machines and 2,000 high-grade anesthesia machines. Domestic manufacturers mainly occupy low-end markets, and high-end markets are monopolized by foreign products. According to the aforementioned anesthesiologist, “The German Drager used to be the leading anaesthetic machine, but the price was too high, and the basic price of all imported machines was more than 300,000. The Oxygen anesthesia machine is more respectful, simpler and more practical, and the price in the imported machine The advantage is obvious. The two years have developed rapidly. Basically, Draeger has won half of the anesthesia machine market.”

In 2006, GE Healthcare incorporated Wuxi Zhongyuan Medical Device Co., Ltd., which was originally the fourth-largest manufacturer of anesthesia machines in China. Through this acquisition, GE is also outside the high-end brand of Europe and the United States, with low-end equipment to enter the primary medical market. "After these two mergers and acquisitions, GE has become the largest supplier of anesthesia machines in the country, followed by Germany's Dräger, British Bess and other import companies. Domestic brands followed, including Beijing Yi'an, Shenzhen Mindray and other companies. The brand's anesthesia machine is generally about 150,000." The aforementioned person told reporters.